Invasive contrast angiography, the x-ray visualization of various body organs via injection of contrast dye delivered through catheters advanced into selected target organs, is widely employed in the evaluation of a variety of medical disorders. Though the techniques employed to perform contrast studies of various vascular beds and organs may vary according to the target, there are many technical and operational issues with regard to both methods and devices that are common to nearly all such angiographic procedures. These include: (1) access devices, which serve as the route of entry into the organ and/or vascular space in general; (2) diagnostic and guiding catheters, which serve to access the specific organ/circulation to be studied [these catheters are typically preformed in specific shapes and sizes designed to access each specific organ/circulation (coronary, cerebral, renal, etc.)]; (3) guide wires, which serve to safely and efficiently facilitate positioning of angiographic and interventional catheters at the target circulation; (4) an angiographic manifold, connected to the back end of the angiographic catheter, which serves to facilitate administration of procedure dependent fluids (saline, contrast dye, certain drugs, etc.); this manifold may contain anywhere from 2- 4 (or occasionally more) ports with stopcocks. These ports are typically connected to flexible tubing which lead to reservoirs of procedure dependent fluids (e.g. contrast dye, saline, etc. ). The back end of the manifold is typically connected to a contrast injection system (either directly or indirectly), which allows administration of the contrast dye (the medium by which angiographic pictures of the target organ are made); contrast dye may be injected through a hand controlled syringe attached to the manifold (either directly or via flexible tubing); alternatively, the injection system may consist of a power injector which is similarly connected to the manifold by plastic tubing.
Many angiographic procedures, in particular coronary angiography and especially coronary vascular interventional procedures such as angioplasty, require frequent intermittent injections of contrast dye. Contrast dye is administered in varying volumes as well as modulated strengths and durations of injection. Intermittent dye injections are critical for optimal positioning of guiding catheters at the target vessels, positioning of guide wires to and through the target areas during catheter interventions (e.g. percutaneous transluminal coronary angioplasty) and for assessment of the results of such interventional procedures.
At present, angiographic procedures are typically performed employing a hand held syringe injector for most contrast injections. However, throughout such procedures there is a requisite need for ongoing and often constant manipulation, adjustment and control of the various catheterization devices (guiding catheter, coronary guide wire and balloon dilatation catheter for angioplasty and sometimes even the vascular access sheath itself), above and beyond the syringe injection system itself. As presently performed, the procedural demands for manipulation of devices precludes one individual operator from simultaneously controlling and manipulating the procedure dependent devices, as well as injecting the contrast dye necessary to perform such complex procedures. At present, in the case of a single operator, such procedures therefore require cumbersome and inefficient juggling of devices. To avoid these inefficiencies and attendant suboptimal procedural performance, most procedures require at least two personnel: (1) The primary procedural operator, always a physician (radiologist, cardiologist or surgeon), who is responsible for control and manipulation of the sheaths, guiding catheters, guide wires and balloon dilatation catheters; and (2) an associate operator (another physician, nurse or a technician) who will act as a first assistant, with main responsibility of injecting dye at the order of the primary operator. This system is not only inefficient from the standpoint of utilization of personnel, but may limit procedural quality and efficiency. That is, the assistant, whose primary role is injecting dye, may not possess the general background, moment-to-moment insights nor have the expertise to deliver the desired volume, rate and duration of contrast at precisely the times the primary operator so desires. Therefore, there is a need for an angiographic system that would facilitate performance of such procedures by a single operator. That is, a device (or devices) that would allow the primary operator to both simultaneously manipulate the various procedure dependent devices (sheaths, catheters and wires) and inject procedure dependent fluids (angiographic contrast).